Effects of Family Work Shop for Children With Developmental Delays: a Randomized Trial

July 4, 2017 updated by: Ru-Lan Hsieh, Taipei Medical University

Therapeutic Effects of Short-term Family-centered Work Shop for Children With Developmental Delays: a Randomized Trial

To identify the therapeutic effects of short-term family-centered work shop for children with developmental delays

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

1. The family work shop has a total of 6 weeks, with 6 families in one course. 2. Two hours per session, one time per week. Aims;

  1. Assess the effects of family work shop for children with developmental delays, including functional performance and health-related quality of life.
  2. Assess the family strain by work shop for parents of children with developmental delays.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 111-01
        • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 M/O to 36 M/O children with developmental delays, under regular rehabilitation programs

Exclusion Criteria:

  • less than 18 M/O and older than 36 M/O failed to obtain written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
children with developmental delays, under regular rehabilitation programs, participate the family work shop family work shop: 6 families in one course, 2 hours per session, one session per week, a total of 6 weeks
Other: family work shop
Children with developmental delays, under regular rehabilitation programs, participate 6 sessions of family work shop The family work shop had 6 families in one course, 2 hours per week, for a total of 6 weeks.
No Intervention: control group
children with developmental delays, under regular rehabilitation programs, not participate the family work shop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline functional performance (scores) at 6 weeks
Time Frame: baseline and up to 6 weeks
Pediatric Outcome Data Collection Instrument
baseline and up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline health-related quality of life (scores) at 6 weeks
Time Frame: baseline and up to 6 weeks
Child Health Questionnaire
baseline and up to 6 weeks
change from baseline caregiver health-related quality of life (scores) at 6 weeks
Time Frame: baseline and up to 6 weeks
World Health Organization Quality of Life: brief form
baseline and up to 6 weeks
change from baseline family strain (scores) at 6 weeks
Time Frame: baseline and up to 6 weeks
Caregiver strain index
baseline and up to 6 weeks
change from baseline family impact
Time Frame: baseline and up to 6 weeks
Pediatric Quality of Life Inventory: Family impact module
baseline and up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 4, 2017

First Submitted That Met QC Criteria

July 4, 2017

First Posted (Actual)

July 6, 2017

Study Record Updates

Last Update Posted (Actual)

July 6, 2017

Last Update Submitted That Met QC Criteria

July 4, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DOH-SKH-106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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